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Product NDC Code | 37000-492 | ||||
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Drug Name | Crest gum detoxify gentle whitening |
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Type | Brand | ||||
Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | PASTE, DENTIFRICE | ||||
RxCUI drug identifier | 416784 | ||||
Application Number | M021 | ||||
Labeler Name | The Procter & Gamble Manufacturing Company | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient Stannous fluoride 0.454% (0.14% w/v fluoride ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children 12 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. do not swallow children under 12 yrs. of age: ask a dentist
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sorbitol, hydrated silica, sodium lauryl sulfate, carrageenan, flavor, sodium gluconate, xanthan gum, zinc citrate, stannous chloride, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses aids in the prevention of cavities helps prevent gingivitis helps interfere with the harmful effects of plaque associated with gingivitis helps control plaque bacteria that contribute to the development of gingivitis
Purpose
Information about the drug product’s indications for use.Purposes Anticavity, antigingivitis toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Crest Gum Detoxify Gentle Whitening Stannous fluoride SUCRALOSE STANNOUS CHLORIDE WATER HYDRATED SILICA CARRAGEENAN SODIUM GLUCONATE XANTHAN GUM ZINC CITRATE SODIUM LAURYL SULFATE SORBITOL SODIUM HYDROXIDE SACCHARIN SODIUM TITANIUM DIOXIDE STANNOUS FLUORIDE FLUORIDE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel - 116 g tube in carton Crest ® FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS Gum Detoxify™ Neutralizes plaque bacteria, even around the gum line GENTLE WHITENING CLINICALLY PROVEN HEALTHIER GUMS NET WT 4.1 OZ (116 g) 492
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-594-4158
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warning Keep out of reach of children under 12 yrs. of age . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API